Because cancer is one of the leading causes of death in adults, the market for cancer drugs has welcomed new treatments with open arms; but are new treatments all...
Pharmaceutical and medical device companies have been complaining for years that the FDA approval process is long and expensive, stifling medical innovation. In response, legislators have included new language...
The FDA’s recent findings over the popular drug Chantix have some painfully obvious advice for doctors: accepting money and gifts from pharmaceutical companies could cloud judgment when prescribing medication....
The U.S. Food and Drug Administration (FDA) released a draft guidance addressing the program that approves third parties to review premarket notification (510(k)) submissions for medical devices. The guidance...
The U.S. Food and Drug Administration is supposed to be the watchdog agency overseeing medical device and drug companies and ensuring they are following regulations, but it appears the...
The U.S. Food and Drug Administration (FDA) announced it will hold a public meeting with the healthcare industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, healthcare...
For people with severe allergies, epinephrine injectors like the EpiPen are a lifeline in dire situations. Living without an EpiPen nearby is risky, but paying for the little injectors...
The U.S. Food and Drug Administration (FDA) takes a lot of criticism, but in its defense, the agency lacks the funding and manpower to address many expressed concerns. But...
It’s not easy being the U.S. Food and Drug Administration (FDA). The agency must straddle a fine line between approving lifesaving medical treatments and protecting consumers from harmful products....
3D Printed medical devices are a new frontier in healthcare, and the FDA is struggling to understand the best way to regulate them. This past May, the agency released...